The Sourcebook For Clinical Research

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The Sourcebook For Clinical Research


The Sourcebook For Clinical Research
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The Sourcebook For Clinical Research


The Sourcebook For Clinical Research
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Author : Natasha Martien
language : en
Publisher: Academic Press
Release Date : 2018-08-01

The Sourcebook For Clinical Research written by Natasha Martien and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-01 with Medical categories.


A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website (https://www.elsevier.com/books-and-journals/book-companion/9780128162422), so that study teams will be compliant and will find all the necessary tools within this book. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly

Clinical Trials Audit Preparation


Clinical Trials Audit Preparation
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Author : Vera Mihajlovic-Madzarevic
language : en
Publisher: John Wiley & Sons
Release Date : 2010-09-29

Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-09-29 with Medical categories.


A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development

Adults A Sourcebook


Adults A Sourcebook
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Author : Joel Fischer
language : en
Publisher: Simon and Schuster
Release Date : 1994-01

Adults A Sourcebook written by Joel Fischer and has been published by Simon and Schuster this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994-01 with Medical categories.


Today, as the legitimacy of various forms of therapeutic intervention is under attack, and as practitioners in all areas of the human services are increasingly held accountable for monitoring and evaluating their practices in an objective manner, a sound familiarity with objective measurement techniques has become essential. In addition, practitioners must also be concerned with satisfying state, agency, or insurance company guidelines. Now, this updated and expanded two-volume edition of Fischer and Corcoran's standard reference enables professionals to gather this vital information easily and effectively. In "Measures for Clinical Practice, Volume 1: Couples, Families and Children and Volume 2: Adults," Joel Fischer and Kevin Corcoran provide an extensive collection of over 320 "rapid assessment instruments" (RAIs), including questionnaires and scales, which assess virtually any problem commonly encountered in clinical practice. All instruments are actually reprinted in the book, and are critiqued by the authors to aid in their selection. The instruments included are brief and easy to administer and will be useful for all types of practice and all theoretical orientations. Introducing the compendium of instruments, Fischer and Corcoran explain the principles of measurement and how to apply them in practice. They explore the range of assessment techniques available, including behavioral observations, rating scales, and client logs, as well as unobtrusive, electromechanical, and standardized measures. After examining the advantages and disadvantages of rapid assessment instruments, they show practitioners how to effectively select, administer, score, and interpret thesemeasures as part of the treatment process. This fully updated and expanded two-volume edition will be essential to every practitioner and student of social work, psychology, psychiatry, nursing, counseling, and the rehabilitative therapies.

The Fundamentals Of Clinical Research


The Fundamentals Of Clinical Research
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Author : P. Michael Dubinsky
language : en
Publisher: John Wiley & Sons
Release Date : 2022-03-02

The Fundamentals Of Clinical Research written by P. Michael Dubinsky and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-03-02 with Medical categories.


This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

Measures For Clinical Practice And Research Volume 2


Measures For Clinical Practice And Research Volume 2
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Author : Kevin Corcoran
language : en
Publisher: Oxford University Press
Release Date : 2013-08-15

Measures For Clinical Practice And Research Volume 2 written by Kevin Corcoran and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-08-15 with Medical categories.


This volume covers assessment for instruments for use with adults.

Measures For Clinical Practice And Research A Sourcebook


Measures For Clinical Practice And Research A Sourcebook
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Author : Joel Fischer
language : en
Publisher: Oxford University Press, USA
Release Date : 2020

Measures For Clinical Practice And Research A Sourcebook written by Joel Fischer and has been published by Oxford University Press, USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with Psychology categories.


"So far in this book we have reviewed the role of measurement to help in monitoring your client's progress and in evaluating your effectiveness using single-system research designs. Our discussion included an overview of the basic principles of reliable and valid measures, the principles related to using measures in practice, and issues regarding interpreting scores. We also discussed some of the different types of measures, including the advantages and disadvantages of rapid assessment instruments. While we clearly believe this type of measure is particularly valuable, we know that there may be times when you will want other measurement tools as well as additional rapid assessment instruments. To this end we presented information on determining what to measure within the context of practice, how to locate measures, and pertinent questions you might ask when evaluating which measure to use. Finally, we presented some guidelines for you to consider when administering instruments"--

Community Public Health In Policy And Practice E Book


Community Public Health In Policy And Practice E Book
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Author : Sarah Cowley
language : en
Publisher: Elsevier Health Sciences
Release Date : 2020-10-30

Community Public Health In Policy And Practice E Book written by Sarah Cowley and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-10-30 with Medical categories.


Designed for public health nurses and health visitors at every stage of their career from students to experienced practitioners Community Public Health in Policy and Practice: A Source Book provides an overview of theoretical constructs and principles for community public health practice, including underpinning research. Written by leading experts the book is designed to support innovation and practice development, including dealing with major policy changes and changes to theory and the evidence base. For this edition the text has been completely reorganised and updated including eight brand new chapters. New chapters include current information and research about contemporary topics such as digital health, economics and implementation science. Updated chapters focus upon relevant knowledge required for current practice, including both seminal theories and research, along with new international frameworks. Brief introduction to the long-lasting impacts of Covid-19, as the pandemic unfolds.